HQ Team
September 23, 2025: The U.S. Food and Drug Administration (FDA) has recently issued a cautionary note regarding the use of acetaminophen (commonly known by the brand name Tylenol) during pregnancy, highlighting a possible association between prenatal acetaminophen exposure and an increased risk of neurodevelopmental disorders such as autism and ADHD in children.
The FDA has initiated a label change process for acetaminophen products to reflect these concerns and issued a letter alerting healthcare providers nationwide about the emerging evidence. However, the FDA emphasizes that while multiple large-scale cohort studies have shown an association, a direct causal link has not been established and acknowledges contradictory findings in the scientific literature. The agency advises that the choice of whether to use acetaminophen during pregnancy should involve a careful risk-benefit assessment, given that it remains the safest over-the-counter option for treating fevers during pregnancy compared to alternatives like aspirin or ibuprofen, which have known fetal risks
The studies cited by the FDA and recent research, including a comprehensive review led by the Icahn School of Medicine at Mount Sinai and Harvard T.H. Chan School of Public Health, support an association between prenatal acetaminophen exposure and neurodevelopmental disorders with suggested biological mechanisms involving oxidative stress and hormonal disruptions that may affect fetal brain development. However, some epidemiological studies, including sibling-controlled analyses, have challenged these findings, showing null effects when controlling for family and genetic factors, making the evidence inconclusive. Experts therefore recommend judicious use—using the lowest effective dose for the shortest time under medical supervision, rather than complete avoidance—to balance managing maternal pain or fever that could otherwise harm the fetus.
Medical community cautious
The medical community’s reaction to the FDA announcement has been mixed but cautious. Professional organizations such as the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) reaffirm the general safety of acetaminophen during pregnancy and urge against unwarranted panic or abrupt discontinuation of treatment for fever or pain without consulting healthcare providers. They emphasize that untreated high fever carries risks for the developing fetus, and a measured approach to use remains the best clinical guidance. Many physicians stress that further scientific research is needed before definitive clinical policy changes are made.
Studies and meta analyses from Nature, Yale and other academic outlets likewise stress that observational associations exist but do not prove cause, and that higher-quality analyses tend to find little or no causal effect once confounders are handled.
Political push questioned
Politically, this FDA caution and related statements have garnered attention due to President Donald Trump’s vocal stance linking acetaminophen use in pregnancy to autism—a connection not conclusively proven by science. Trump, accompanied by Health Secretary Robert F. Kennedy Jr., has publicly advised pregnant women to avoid acetaminophen and linked vaccines and acetaminophen to autism risks, positions that conflict with expert consensus and FDA cautionary but balanced messaging. This has sparked controversy and debate in public health and media, with pharmaceutical makers defending acetaminophen’s safety and medical authorities calling for careful interpretation of the evidence without undermining necessary pain and fever management during pregnancy. The administration’s push for label changes coincides with efforts to raise public awareness but has also been viewed as politically charged given the history of vaccine misinformation and skepticism toward drug safety communicated by political figures.
